1: Final Report on the Safety Assessment of Sodium Lauryl Sulfoacetate

1987 ◽  
Vol 6 (3) ◽  
pp. 261-277 ◽  
Keyword(s):  
Clinical Studies ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Sodium Lauryl Sulfate ◽  
Skin Irritation ◽  
Final Report ◽  
Lauryl Sulfate ◽  
Cosmetic Products ◽  
Cosmetic Product ◽  
Ocular Irritation

Sodium Lauryl Sulfoacetate is a detergent used in cosmetic products. A 12% solution of the ingredient was slightly toxic to rats in an acute oral study. No treatment-related effects of significance were noted in rats in a subchronic study at a dose of 75 mg/kg/day. Some effects were observed at 250 and 750 mg/kg/day. Minimal to slight ocular irritation occurred in rabbits when tested with 3.0% Sodium Lauryl Sulfoacetate. A diluted product tested at 1% Sodium Lauryl Sulfate was nonirritating to the genital mucosa of rabbits. No skin irritation, sensitization, or phototoxicity was noted in guinea pigs exposed to a cosmetic product containing 2% Sodium Lauryl Sulfoacetate. Cosmetic products containing up to 16% Sodium Lauryl Sulfoacetate were nonmutagenic in the Ames Salmonella/microsome assay, both with and without activation. In clinical studies, Sodium Lauryl Sulfoacetate was a mild to strong skin irritant but not a sensitizer at concentrations up to 2.0%. The irritant effects are similar to those produced by other detergents, and the severity of the irritation appears to increase directly with concentration. It is concluded that Sodium Lauryl Sulfoacetate is safe for use in cosmetic products in the present practices of use and concentration.

2: Final Report on the Safety Assessment of Propylene Carbonate

1987 ◽  
Vol 6 (1) ◽  
pp. 23-51 ◽  
Keyword(s):  
Aqueous Solution ◽  
Dna Repair ◽  
Propylene Carbonate ◽  
Clinical Studies ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Final Report ◽  
Clear Liquid ◽  
Cosmetic Products ◽  
Ocular Irritation

Propylene Carbonate is a nonviscous, clear liquid that is used in cosmetic products at concentrations ranging from 0.1% to 5%. Undiluted Propylene Carbonate produced minimal to moderate ocular irritation and slight erythema in rabbits. The dermal LD50 in rabbits of the undiluted ingredient was >20 ml/kg. Undiluted Propylene Carbonate was nontoxic by inhalation to dogs and guinea pigs in a 21-day study. Propylene Carbonate was negative for mutagenicity in the Ames Assay, and negative for genotoxicity in the Rat He-patocyte Primary Culture/DNA Repair Test. In clinical studies, undiluted Propylene Carbonate caused moderate skin irritation, whereas 5 and 10% Propylene Carbonate in aqueous solution produced no skin irritation or sensitization. Cosmetic products containing up to 20% Propylene Carbonate were essentially nonsensitizing and, at most, moderately irritating to human skin, nonphototoxic, and nonphotosensitizing. It is concluded that Propylene Carbonate is safe as a cosmetic ingredient in the present practices of use and concentration.

scholarly journals 7 Final Report on the Safety Assessment of Hydrolyzed Collagen

1985 ◽  
Vol 4 (5) ◽  
pp. 199-221 ◽  
Keyword(s):  
Clinical Studies ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Final Report ◽  
Cosmetic Products ◽  
Full Strength ◽  
Hydrolyzed Collagen ◽  
Cosmetic Formulations ◽  
Animal Toxicity

Hydrolyzed Collagen is a hydrolysate derived from animal byproducts. It is used in cosmetic products as a conditioner or moisturizer at concentrations less than 5 percent. Hydrolyzed Collagen was practically nontoxic when administered orally or dermally in acute animal toxicity studies. This ingredient was minimally irritating to rabbit eyes when tested full-strength. Primary skin irritation tests in rabbits indicated that Hydrolyzed Collagen was nonirritating or minimally irritating when tested full-strength. Subchronic dermal studies on 2 cosmetic formulations containing 2 percent Hydrolyzed Collagen were negative for systemic toxicity. Hydrolyzed Collagen was nonsensitizing in guinea pigs. In clinical studies, Hydrolyzed Collagen produced no skin irritation, sensitization, or indication of phototoxicity. On the basis of the available animal and clinical data, it is concluded that Hydrolyzed Collagen is safe as a cosmetic ingredient in the present practices of use and concentration.

Final Report on the Safety Assessment of Acetamide MEA

1993 ◽  
Vol 12 (3) ◽  
pp. 225-236 ◽  
Keyword(s):  
Guinea Pigs ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Nitroso Compounds ◽  
Final Report ◽  
Skin Exposure ◽  
Ocular Irritation ◽  
Cosmetic Formulations ◽  
A Minor ◽  
Primary Irritation

Acetamide MEA is used in cosmetics as a skin conditioning agent-humectant and hair conditioning agent. Oral LD50s of 27 g/kg were reported for Acetamide MEA in rats. No rabbits died following an acute dermal exposure of 20 ml/kg Acetamide MEA. In ocular irritation studies, 70% Acetamide MEA and cosmetic formulations containing 1.3% Acetamide MEA were classified as nonocular irritants in rabbits. Only mild skin irritation occurred following a 24-h skin exposure to undiluted Acetamide MEA. In the maximization test, Acetamide MEA was classified as a nonsensitizer in guinea pigs when tested at a concentration of 5.0%. Neither primary irritation nor sensitization reactions to 7.5% Acetamide MEA were observed in a human repeated insult patch test. Acetamide MEA was not nonmutagenic in the Ames assay. In the presence of nitrosating agents, Acetamide MEA may form N-nitroso compounds; acetamide may be a minor impurity in Acetamide MEA. On the basis of the data presented in this report, it is concluded that Acetamide MEA is safe as a cosmetic ingredient at concentrations not to exceed 7.5% in leave-on products and is safe in the present practice of use in rinse-off products. Cosmetic formulations containing Acetamide MEA should not contain nitrosating agents or significant amounts of free acetamide.

6: Final Report on the Safety Assessment of Panthenol and Pantothenic Acid

1987 ◽  
Vol 6 (1) ◽  
pp. 139-162 ◽  
Keyword(s):  
Safety Assessment ◽  
Skin Irritation ◽  
Allergic Sensitization ◽  
Pantothenic Acid ◽  
Final Report ◽  
Test Substance ◽  
Cosmetic Products ◽  
Toxicological Effects ◽  
Ocular Irritation ◽  
Low Concentrations

Panthenol is the alcohol analogue of Pantothenic Acid (vitamin B3). The LD50for D-Panthenol administered orally to mice was 15 g/kg. No toxicological effects were associated with the subchronic and/or chronic oral administration of Panthenol to rats. Minimal cutaneous hyperkeratosis was noted in rats in a subchronic dermal study of creams containing 0.2% Panthenol. In ocular irritation studies involving rabbits, concentrations up to 2% produced, at most, slight conjunctival redness and chemosis. Panthenol (100%) and products containing Panthenol (0.5% and 2%) administered to rabbits during skin irritation studies caused reactions ranging from no skin irritation to moderate-to-severe erythema and well-defined edema. Neither teratogenic nor fetotoxic effects were noted in the offspring when rats were fed calcium pantothenate prior to mating and throughout gestation. Skin irritation and sensitization studies of cosmetic products at concentrations up to 0.5% indicated that they were, at most, mild irritants but did not induce allergic sensitization. No test substance-related observations of eye irritation were reported for 23 subjects receiving instillations of products containing 0.1% Panthenol. Mutagenicity and carcinogenicity data were not available for the safety assessment of Panthenol. It is noted that the level of this ingredient required by humans exceeds the amount that could be absorbed from the low concentrations used in cosmetic products. The human metabolic requirement would preclude the likelihood of genotoxicity. It is concluded that Panthenol and Pantothenic Acid are safe as presently used in cosmetics.

8 Final Report on the Safety Assessment of Sodium Cetearyl Sulfate

1992 ◽  
Vol 11 (1) ◽  
pp. 145-155 ◽  
Keyword(s):  
Test Data ◽  
Safety Assessment ◽  
Sodium Lauryl Sulfate ◽  
Safety Evaluation ◽  
Final Report ◽  
Lauryl Sulfate ◽  
Chemical Similarity ◽  
Ocular Irritation ◽  
Safety Test ◽  
Cosmetic Ingredients

Sodium Cetearyl Sulfate is the sodium salt of a mixture of cetyl and stearyl sulfate which is used as a surfactant and cleansing agent in cosmetics at concentrations ranging from ≥ 0.1 to 25.0%. The LD50 was not achieved in two studies in which rats received a single oral dose of 5.0 ml/kg. In ocular irritation tests, 20.0% aqueous Sodium Cetearyl Sulfate was not irritating to the eyes of rabbits. Twenty percent Sodium Cetearyl Sulfate was not irritating to the skin of rabbits. In a guinea pig sensitization study, Sodium Cetearyl Sulfate was not a sensitizer. Sodium Cetearyl Sulfate is less irritating to the skin than Sodium Lauryl Sulfate, whose safety test data are summarized in the report. Due to the chemical similarity of these two cosmetic ingredients, the safety test data on Sodium Lauryl Sulfate was considered to be applicable to the safety evaluation of this ingredient. On the basis of the animal and clinical data on Sodium Cetearyl Sulfate and Sodium Lauryl Sulfate as presented in the report, it is concluded that Sodium Cetearyl Sulfate is safe as a cosmetic ingredient in the present practices of use and concentration.

Final Report of the Safety Assessment for PEG-75 Lanolin, PEG-20 Lanolin, PEG-27 Lanolin, PEG-30 Lanolin, PEG-40 Lanolin, PEG-50 Lanolin, PEG-60 Lanolin, and PEG-85 Lanolin

1982 ◽  
Vol 1 (4) ◽  
pp. 91-102 ◽  
Keyword(s):  
Polyethylene Glycol ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Final Report ◽  
Cosmetic Products ◽  
Glycol Ethers ◽  
Eye Irritation ◽  
Oil Water ◽  
Available Information

PEG Lanolins are the polyethylene glycol ethers of whole lanolin. They are widely used in cosmetics as auxiliary oil/water emulsifiers at concentrations of up to 25%. PEG Lanolins were found to be nontoxic in acute oral, dermal, and inhalation studies at varying concentrations. They caused little or no eye irritation in rabbits at concentrations of 50-100%. PEG Lanolins at 10-100% caused mild or negligible skin irritation and were reported to be nonsensitizing in guinea pigs. PEG Lanolins were reported to be nonirritating and nonsensitizing in patients at concentrations from 10-60%. On the basis of the available information, it is concluded that the PEG-75 Lanolin Group is safe as presently used in cosmetic products.

2 Final Report on the Safety Assessment of p-Hydroxyanisole

1985 ◽  
Vol 4 (5) ◽  
pp. 31-63 ◽  
Keyword(s):  
Guinea Pigs ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Tumor Promoter ◽  
Final Report ◽  
Skin Sensitization ◽  
Cosmetic Products ◽  
Rabbit Skin ◽  
Ames Assay

p-Hydroxyanisole is used as an antioxidant in cosmetic products at concentrations of up to 1.0 percent. The acute oral LD50 of p-Hydroxyanisole in rats was estimated as 1630 mg/kg. Undiluted p-Hydroxyanisole is a severe skin and ocular irritant in rabbits but produced minimal eye irritation at 0.1 percent and minimal rabbit skin irritation at 5 percent. Skin sensitization to p-Hydroxyanisole occurred when guinea pigs were treated at 0.5 M. p-Hydroxyanisole is a skin-depigmenting agent at concentrations approximating those used in cosmetic products. p-Hydroxyanisole was nonmutagenic in the Ames assay. No local toxic changes or tumors were observed following long-term application of 5 and 10 percent p-Hydroxyanisole. The antioxidant was inactive as a tumor promoter. Solutions of p-Hydroxyanisole produced embryotoxicity but not teratogenicity. The function of p-Hydroxyanisole in cosmetics is that of an antioxidant; it is not intended for use as a skin lightener or skin-depigmenting agent. Because of the depigmenting action of p-Hydroxyanisole in black guinea pigs at reported concentrations approaching those used in cosmetics, it is concluded that p-Hydroxyanisole is unsafe for use as a cosmetic ingredient.

Final Report on the Safety Assessment of Cetyl Lactate and Myristyl Lactate

1990 ◽  
Vol 1 (2) ◽  
pp. 97-107 ◽  
Keyword(s):  
Safety Assessment ◽  
Skin Irritation ◽  
Final Report ◽  
Cosmetic Products ◽  
Rabbit Skin ◽  
Ocular Irritation ◽  
Myristyl Alcohol ◽  
Irritation Test ◽  
Skin Irritation Test ◽  
Available Information

Cetyl Lactate and Myristyl Lactate are the esters of lactic acid and either cetyl or myristyl alcohol. They are used in a wide variety of cosmetic products up to a maximum concentration of 25%. The acute oral LD50 of Cetyl Lactate is estimated from studies with rats to be greater than 20 g/kg. Cetyl Lactate was shown to be minimally irritating to rabbit skin and nonirritating or only slightly irritating to rabbit eyes in Draize irritation tests. At 25%, Cetyl Lactate produced no signs of toxicity or irritation in a 30-day rabbit-skin irritation study. Cetyl Lactate was found to be minimally irritating and nonsensitizing to human skin at concentrations up to 5%. The acute oral LD50 of Myristyl Lactate is estimated from studies with rats to be greater than 20 g/kg. Myristyl Lactate was shown to be minimally irritating in Draize primary skin irritation tests, but one contradictory study concluded that undiluted Myristyl Lactate produced moderate irritation. It produced no signs of ocular irritation in Draize rabbit eye irritation tests. Mild irritation was elicited by a formulation in a modified Draize rabbit skin irritation test. The same formulation was found to be nonirritating and nonsensitizing in a human repeated insult patch study. Based on the available information, it is concluded that Cetyl Lactate and Myristyl Lactate are safe in the present practices of use.

scholarly journals 4 Final Report on the Safety Assessment of Phenyl Trimethicone

1986 ◽  
Vol 5 (5) ◽  
pp. 353-371
Keyword(s):  
Absorption Spectrum ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Metabolic Activation ◽  
Final Report ◽  
Cosmetic Products ◽  
Ames Assay ◽  
Ocular Irritation ◽  
Irritation Test ◽  
Uv Absorption Spectrum

Phenyl Trimethicone is a silicon polymer used in a variety of cosmetic products at concentrations up to 5%. In acute oral studies, Phenyl Trimethicone was relatively nontoxic in rats and was nontoxic in acute and subchronic dermal studies. Phenyl Trimethicone was nonirritating to the skin of rabbits under both intact and abraded conditions and was not a sensitizer to guinea pigs. The ingredient was not an eye irritant when evaluated by the Draize ocular irritation test. Phenyl Trimethicone was nonmutagenic both with and without metabolic activation when evaluated in the Ames assay. Phenyl Trimethicone was not teratogenic in rats and rabbits when applied dermally at doses of up to 500 mg/kg per day, although an increase in the number of resorptions was noted in two of three studies (statistically significant in only one). A dose of 200 mg/kg per day indicated that a fetotoxic dose was being approached. The doses tested are comparatively greater than the concentrations used in cosmetic products. Phenyl Trimethicone is neither an irritant nor a sensitizer to humans. No photosensitization data are available on Phenyl Trimethicone; however, the UV absorption spectrum indicated only weak absorbance at 327 nm. Based on the animal and human data included in this report, it is concluded that Phenyl Trimethicone is safe as a cosmetic ingredient in the present practices of use and concentration.

1 Final Report on the Safety Assessment of Isostearyl Neopentanoate

1985 ◽  
Vol 4 (3) ◽  
pp. 1-22 ◽  
Keyword(s):  
Test Data ◽  
Clinical Studies ◽  
Safety Assessment ◽  
Final Report ◽  
Cosmetic Products ◽  
Short And Long Term ◽  
Cosmetic Formulation

Isostearyl Neopentanoate, the ester of Isostearyl Alcohol and Neopentanoic Acid, is used in cosmetic products as an emollient at concentrations up to 50 percent. The undiluted ingredient at doses up to 4 ml/kg was shown to be relatively non-toxic in short-and long-term feeding studies. Test data from animal and clinical studies indicate the undiluted ingredient is neither an irritant nor a sensitizer. A cosmetic formulation containing 16 percent Isostearyl Neopentanoate produced no phototoxicity and no photoallergenicity. Mutagenicity, carcinogenicity, and teratogenicity data were not available. Isostearyl Neopentanoate was not considered to be a significant comedogenic agent. On the basis of available data, it is concluded that this ingredient is safe as a cosmetic ingredient in its present practices of use.

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